| CTRI Number |
CTRI/2025/07/090344 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Patient Positions During Surgery for Thighbone Fractures: Which Position Helps Bone Heal Straighter |
|
Scientific Title of Study
|
ROMANOFF - Rotational Malalignment in Nailing of Femur Fractures - A Comparative Randomized Study between Supine and Lateral Position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokulprasath S |
| Designation |
MS ortho, Assistant professor |
| Affiliation |
Christian medical College vellore |
| Address |
7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore, Ranipet campus,Ratnagiri Kilminnal
Vellore TAMIL NADU 632517 India |
| Phone |
9994390198 |
| Fax |
|
| Email |
gokulprasath92@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gokulprasath S |
| Designation |
MS ortho, Assistant professor |
| Affiliation |
Christian medical College vellore |
| Address |
7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore Ranipet campus,Ratnagiri Kilminnal
Vellore TAMIL NADU 632517 India |
| Phone |
9994390198 |
| Fax |
|
| Email |
gokulprasath92@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gokulprasath S |
| Designation |
MS ortho, Assistant professor |
| Affiliation |
Christian medical College vellore |
| Address |
7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore,Ranipet campus,Ratnagiri Kilminnal
Vellore TAMIL NADU 632517 India |
| Phone |
9994390198 |
| Fax |
|
| Email |
gokulprasath92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Vellore, Tamilnadu, India - 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College Vellore, Tamilnadu, India - 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gokulprasath |
Christian Medical College |
Department of Trauma orthopaedics, Ranipet campus, Ratnagiri Kilminnal - 632517 Vellore TAMIL NADU |
9994390198
gokulprasath92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lateral position nailing |
Nailing of femur Fractures which will be done in lateral position on radiolucent table |
| Comparator Agent |
Supine position nailing |
Nailing of femur Fractures which will be done in supine position on fracture table |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult aged 18 years of age or older presenting to casualty or OPD
Diaphyseal femur fractures A0 32 appropriate for antegrade nail fixation
Ability to obtain perioperative imaging (CT scans)
Provision of informed consent
Enrolled within 3 weeks of femoral shaft fixation
Open fractures Gustilo Anderson type 1, 2, 3A
Bilateral femur fractures |
|
| ExclusionCriteria |
| Details |
Ipsilateral neck of femur fractures
Distal femur shaft fractures amenable to retrograde nail fixation
Ipsilateral tibia fractures
Ipsilateral acetabular fractures
Periprosthetic fractures
Pathological fractures
Open fractures Gustilo Anderson type 3B, 3C
Inability to be positioned in lateral decubitus because of a concomitant injury
Contraindications to CT imaging including impaired kidney/liver function, or lack of timely availability
Pregnancy (due to decubitus positioning) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post-operative rotational alignment of operative limb with CT scan axial images after surgery using 2 positions
|
1st postoperative day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain score at 6 weeks, 3 months & 6 months using VAS score
Functional score by a LEFS (Lower Extremity Functional Scale) score at 6 weeks, 3 months & 6 months.
Knee ROM at 6 weeks, 3 months & 6 months.
Time to union
Operative time between two groups
Number of open reductions
Intraoperative complications such as perineal skin & soft tissue compromise
|
6 weeks, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Femur shaft fractures are among the most common orthopaedic injuries, and intramedullary nailing is the standard treatment of choice for these fractures. It aims to achieve alignment, length, and stabilization with minimal soft tissue dissection. The advantages of the nail include early weight-bearing and joint mobilization. There are many ways to perform fracture fixation, including variations in the entry point, implant choice, patient position, and operating table. Antegrade intramedullary nailing is the preferred choice for most femur shaft fractures, except for distal third shaft fractures, which are sometimes amenable to retrograde nailing. Common positions used for antegrade nailing of femur fracture fixation are: Supine position on a fracture table Lateral decubitus position on a radiolucent table
The use of a fracture table with patient in supine position has become the preferred treatment for most of these fractures. Literature shows that there can be rotational malalignment following antegrade intramedullary nailing of femur fractures. Malrotation mainly occurs because the traction table can easily overpower the patient’s resting muscle tension, as well as due to the surgeons manipulation when reducing the fracture during positioning. It has been hypothesized that the lateral position provides easier access to the entry point, facilitates fracture reduction, and allows for rapid implant positioning. Although rotational malalignment can occur in both positions, according to the literature, the lateral position provides better fracture reduction and control of fracture fragments. There are many ways to determine femoral rotation which includes clinical assessment, radiological measurement, Ultrasound and CT. Unlike when using radiography or ultrasound, the position of the patient does not influence the accuracy of CT measurement of femoral rotation. Hence in this study we plan to use CT as a definitive tool to evaluate the impact of patient positioning on rotational alignment.
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